Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/08/2015
Date assigned
22/09/2015
Last edited
21/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Recent studies suggest that dairy may affect the body in different ways depending on the form in which it is eaten. This study will examine the effect of dairy fat, in three different forms (presented in three different food types) on how much lipid (fat) is present in the blood, and other aspects of metabolic health (for example, the amount of energy used by the body, or how substances are broken down/made in the body). This study aims to improve understanding about how fats are processed in the body.

Who can participate?
Healthy adults, between the ages of 50-70, with a BMI of over 25kg/m2, and not on a prescribed diet.

What does the study involve?
At the start of the study, all participants attend the UCD volunteer suites for an assessment. This includes them having a fasting blood sample and body measurements taken. They also have their diet assessed by a trained nutritionist, involving the completion of a questionnaire on that they eat and when and what they have eaten the day the day before. The participants are then randomly allocated into one of four groups and are given their test foods, on portioned packs with instructions on how to eat them, for the next 6 weeks. Those in group one are given dairy fat in the form of regular fat cheese. Those in group two are given dairy fat in the form of reduced fat cheese plus butter. Those in group three are given dairy fat in the form of butter alone. Those in group four are controls and are asked to limit dairy intake to very small amounts, but to otherwise maintain their normal diet. During the 6 weeks of the study, all participants are asked to complete more dietary assessments over the phone with a nutritionist and also to record whether they have stuck to the diet or not. At the end of the 6 weeks, the participants return to the volunteer suites, and complete the same tests as they did at the beginning of the study. A random selection of people are then asked to do a ‘metabolic challenge’ test. They are given a high fat food to eat. Blood samples are then taken over the next 5 hours to monitor how quickly their body responds to the challenge. A small cannula, like a small tap, is inserted into the vein to avoid multiple pricks for blood tests. The participants are given more food to eat after the test.

What are the possible benefits and risks of participating?
There are no known benefits of taking part. However, those who take part will be contributing to research. There may be some slight discomfort upon the blood samples but it will be conducted by trained experienced professionals and will only consist of a small amount of blood taken (less than a blood donation). There are no other known risks associated with taking part in this study.

Where is the study run from?
UCD Institute of Food and Health (Ireland)

When is the study starting and how long is it expected to run for?
September 2015 to December 2016

Who is funding the study?
Food for Health Ireland (Ireland)

Who is the main contact?
Dr Emma Feeney

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Feeney

ORCID ID

http://orcid.org/0000-0003-3234-6340

Contact details

UCD School of Agriculture & Food Science
Institute of Food and Health
Science Centre - South
University College Dublin
Belfield
Dublin
D04 N2E5
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TC-2013-001

Study information

Scientific title

The effect of dairy fat on metabolic health - understanding the 'matrix' effect of cheese

Acronym

Study hypothesis

To establish whether the form (matrix) in which dairy fat is consumed has an effect on parameters of metabolic health

Ethics approval

University College Dublin Human Research Ethics Committee, 31/07/15, ref: LS-15-44-Feeney-Gibney

Study design

Single-centre intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Obesity

Intervention

Participants will be randomised into one of four groups, each receiving dairy fat in different forms:
Group 1: To receive dairy fat in the form of regular fat cheese
Group 2: To receive dairy fat in the form of reduced fat cheese plus butter
Group 3: To receive dairy fat in the form of butter alone
Group 4: A control group asked to limit dairy intake to very small amounts, to consume no cheese/cheese products during the wash out period and to maintain habitual diet throughout the 6 week intervention period

A subset of subjects from each group will then undergo a metabolic challenge in which high fat food is consumed, blood lipid profiles are measured over a course of four hours.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Fasting blood markers of metabolic health following 6 weeks daily consumption of dairy fat, in 3 different matrices.
A subset of subjects (n=24) will give multiple blood samples (8 in total) over 5 hours. Analysis will be performed at all time points.

Secondary outcome measures

Postprandial blood-lipid and glucose following an oral lipid challenge in a subset of subjects.

Overall trial start date

01/09/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy, on no medication
2. Not following a prescribed diet for any reason (weight loss, cholesterol etc)
3. Male or female, aged between 50-70
4. BMI >25 kg/m2

Participant type

Healthy volunteer

Age group

Other

Gender

Both

Target number of participants

N=240

Participant exclusion criteria

1. Outside the specified age
2. BMI <25 kg/m2
3. Anyone who is currently taking prescribed medication for cholesterol-reduction purposes
4. Anyone following any specific diet to control or modify their cholesterol or weight

Recruitment start date

01/09/2015

Recruitment end date

01/10/2016

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Dublin Institute of Food and Health
University College Dublin School of Agriculture & Food Science Science Centre - South University College Dublin Belfield
Dublin
D04 N2E5
Ireland

Sponsor information

Organisation

Food for Health Ireland

Sponsor details

UCD Institute of Food and Health
Level 2
Science Centre South
University College Dublin
Belfield
Dublin
D04 N2E5
Ireland

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Food for Health Ireland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publications planned to include (but not limited to):
1. Changes in anthropometry (if any) following 6 weeks of different diets
2. Changes in blood lipid markers
3. Changes in fasting glucose/insulin levels
A further publication will examine postprandial responses to a lipid tolerance test , before and after 6 weeks consumption of the different diets.
Publications are planned for submission to high impact clinical nutrition journals.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes